Colistimethate

   
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Colistimethate


Drug - Colistimethate
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Colistimethate Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 150MG BASE/VIAL
The potency of the active ingredient(s), Colistimethate Sodium. May repeat for multiple part products.

Applicant - PHARMA TEK
The firm name holding legal responsibility for Colistimethate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 064216
The FDA assigned number to Colistimethate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Colistimethate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Feb 26, 1999
The date Colistimethate was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Colistimethate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Colistimethate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharma Tek Inc
The full name of the firm holding legal responsibility for the new application of Colistimethate.

Colistimethate